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Trade groups said phenibut is neither an approved drug in the United States nor meets regulatory requirements to be sold in or as a dietary supplement.

Nov 05, 2018

Editor's note: This article was updated Nov. 6 with comments from FDA.

“Phenibut,” a substance developed as a drug in the former Soviet Union for its supposed brain-enhancing properties, is being unlawfully marketed in products fraudulently labeled as a dietary supplement, four industry trade associations warned Monday.

The trade groups said the substance is neither an approved drug in the United States nor meets regulatory requirements to be sold in or as a dietary supplement.

“The ingredient should be considered dangerous and has been associated with potentially serious side effects and great risk for addiction,” the trade organizations cautioned in a news release. “The responsible dietary supplement industry learned that phenibut has been found in adulterated products fraudulently labeled as dietary supplements and is warning consumers to avoid purchasing any products with this ingredient.”

The industry notified FDA and contacted several online retailers selling products containing phenibut, urging them to immediately remove the items from their digital shelves, according to the news release. The trade groups said they support FDA’s legal authority to immediately remove the phenibut-containing products from the market.

“Each association and its member companies prioritizes the safety and well-being of consumers above all else,” the news release stated. “The responsible industry is committed to providing the public with safe, high-quality dietary supplement products that provide many positive benefits to promote better health and wellness.”

Corinne Newhart, an FDA spokeswoman, said her agency was aware of the trade associations’ announcement and appreciated their “commitment to promoting the integrity of the dietary supplement marketplace.”

“We are currently in the process of evaluating the safety and legality of this ingredient,” Newhart said in an emailed statement, referencing phenibut. “The FDA is committed to doing everything within its resources and authorities to identify and remove unsafe and illegal products from the market, and we continue to work collaboratively with all of our stakeholders to help ensure that products marketed as dietary supplements are safe, well-manufactured, and accurately labeled.”

She added: “The FDA advises consumers to talk to their doctor, pharmacist, or other healthcare professional before deciding to purchase or use a dietary supplement. For example, some supplements might interact with medicines or other supplements. Also, if claims sound too good to be true, they probably are. Consumers need to be mindful of product claims such as ‘works better than [a prescription drug],’ ‘totally safe,’ or has ‘no side effects.’ And finally, if a consumer thinks that a dietary supplement might have caused a reaction or illness, they should immediately stop using the product, contact their healthcare provider, and submit a complaint to the FDA using the Safety Reporting Portal.”